Table 4.
Pharmacokinetic data of test vs. reference after a 5 mg dose (one 5 mg Tablet) single oral dose (35 healthy volunteers).
| Pharmacokinetic parameter | Test | Reference |
|---|---|---|
| Cmax (pg/mL) | 2079.2 | 2058.1 |
| AUC0−t (pg h/mL) | 46,361.8 | 46,696.0 |
| aUC0−α (pg h/mL) | 53,250.1 | 54,025.6 |
| tmax (h) | 4.5 | 5 |
| t1/2 (h) | 24.5 | 24.3 |
| Ke | 0.02822 | 0.02849 |
AUC0−∞: Area under the curve extrapolated to infinity.
AUC0−t: Area under the curve up to the last sampling time.
Cmax: The maximum plasma concentration.
tmax: The time to reach peak concentration.
Ke: Elimination rate.